Ask the Experts: Dengue: Vaccine Products

Dengvaxia (Sanofi) is a live-attenuated, chimeric tetravalent dengue vaccine built on a yellow fever 17D backbone. It is designed to protect against all four DENV serotypes. It was licensed by the FDA in May 2019 for children and adolescents age 9 through 16 years with a confirmed history of previous dengue infection. FDA lowered the youngest age for licensed use from 9 years to 6 years in 2023; however, CDC’s recommendations to begin routine vaccination of children with serologic evidence of prior dengue infection at age 9 years remains unchanged. The recommendation for vaccination is restricted to people age 9 through 16 years with confirmed previous DENV infection because Dengvaxia is associated with an increased risk for severe dengue in those who experience their first natural infection (i.e., primary infection) after vaccination.

In 2024, Sanofi announced plans to discontinue production of Dengvaxia in the third quarter of 2026 due to low global demand. Other dengue vaccines are in late stages of development; however, there are no other licensed dengue vaccines available in the United States.

Vaccine efficacy (VE) during clinical trials in multiple countries ranged from 76% to 82%. VE varied by serotype and was highest for DENV-4 (89% point estimate) and lowest for DENV-1 and DENV-2 (67% point estimate). Among study participants ages 9 through 16 years who developed protective antibodies, the vaccine reduced their risk of hospitalization with dengue by 79% and reduced their risk of severe dengue by 84% over the 5-year follow-up period after vaccination. Studies are ongoing to determine how long protection from hospitalization or severe disease may last, but current evidence show protection lasting at least 6 years after the last dose of vaccine.